Richard T Griffey, Lee M Adler, David C Stockwell, Peter D Hibbert, Dorthe O Klein, Rene Schwendimann, Andrew D Auerbach, Rachel Ancona, Ryan M Schneider, David Classen, Christopher R Carpenter, Anne W S Rutjes, Maria Unbeck
{"title":"Standard Elements in Studies of Adverse Events and Medical Error (SESAME): explanation and elaboration.","authors":"Richard T Griffey, Lee M Adler, David C Stockwell, Peter D Hibbert, Dorthe O Klein, Rene Schwendimann, Andrew D Auerbach, Rachel Ancona, Ryan M Schneider, David Classen, Christopher R Carpenter, Anne W S Rutjes, Maria Unbeck","doi":"10.1097/PTS.0000000000001584","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001584","url":null,"abstract":"<p><p>Studies that evaluate adverse events and medical error often suffer from incomplete and inadequate reporting, which affects the interpretability and reproducibility of their findings. To address this, we developed the 44-item Standard Elements in Studies of Adverse Event or Medical Error (SESAME) checklist using a rigorous process following the recommendations of the Enhancing the QUAlity and Transparency Of health Research Network. The aim of this manuscript is to explain the scope and aim of the checklist by providing a detailed explanation of each item in the SESAME checklist, illustrated by examples from selected studies of adverse events and medical error.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148945870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Richard T Griffey, David C Stockwell, Lee M Adler, Rachel Ancona, David Classen, Ryan M Schneider, Anne Ws Rutjes, Christopher R Carpenter, Maria Unbeck
{"title":"Standard Elements in Studies of Adverse Events and Medical Error: the SESAME statement.","authors":"Richard T Griffey, David C Stockwell, Lee M Adler, Rachel Ancona, David Classen, Ryan M Schneider, Anne Ws Rutjes, Christopher R Carpenter, Maria Unbeck","doi":"10.1097/PTS.0000000000001583","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001583","url":null,"abstract":"<p><p>Variability and persistent gaps in reporting have been consistently observed across studies evaluating adverse events in healthcare, dating back to the early days of the patient safety movement. Incomplete descriptions-particularly missing details regarding study design, conduct, methodologies and applied definitions-impede interpretation, hinder critical appraisal and limit reproducibility. These deficiencies not only obstruct a shared understanding of findings but also diminish the overall impact such studies may have on patient safety initiatives and policy development. To address these challenges and enhance the quality of reporting, we developed the SESAME (Standard Elements in Studies of Adverse Events and Medical Error) reporting guideline. SESAME is a 44-item checklist designed to support comprehensive and standardised reporting in studies evaluating potential patient harm. The guideline was developed over a 2-year period by an international, multidisciplinary panel through a consensus-driven process aligned with EQUATOR (Enhancing the QUAlity and Transparency Of Health Research Network) standards.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148945980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marta Charlo-Bernardos, Pilar López-Cuartero, Jesica Montero-Marco, Ana Anguas-Gracia, Elena Altarribas-Bolsa, Carlos Aibar-Remón, Ana Mª Pelleja-Guardiola, Beatriz Herrero-Cortina
{"title":"Knowledge and Attitudes Toward Patient Safety Culture Among Nursing Students: Impact of an Interactive Educational Methodology in a Tertiary-level Hospital.","authors":"Marta Charlo-Bernardos, Pilar López-Cuartero, Jesica Montero-Marco, Ana Anguas-Gracia, Elena Altarribas-Bolsa, Carlos Aibar-Remón, Ana Mª Pelleja-Guardiola, Beatriz Herrero-Cortina","doi":"10.1097/PTS.0000000000001588","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001588","url":null,"abstract":"<p><strong>Objectives: </strong>Promoting a culture of patient safety is essential in nursing education to ensure high-quality care and professional accountability. However, the use of practical, interactive approaches, especially during clinical placements, remains underexplored. This study aimed to evaluate the impact of an interactive educational methodology on nursing students´ self-reported knowledge and attitudes towards patient safety culture during clinical placements.</p><p><strong>Methods: </strong>A pre-post quasi-experimental study was conducted among nursing students during clinical placements at a tertiary hospital. The Latino Student Patient Safety Questionnaire was administered before a structured, interactive training program incorporating case-based learning, debates, and gamification, and again after completion of both the training and the 8-week clinical placement. Five dimensions were assessed: openness in communication, proactive attitude toward risk prevention, error awareness, understanding of human factors, and system complexity/interrelationships.</p><p><strong>Results: </strong>A total of 543 nursing students participated (84% female; 64% in their final year), of whom 64% completed the follow-up. The baseline mean±SD patient safety score was 3.5 (0.4). Proactive attitude and understanding of human factors were rated highest, while error awareness and interdisciplinary relationships scored lowest. No significant change was observed in the overall score (mean difference=0.0; 95% CI: -0.1 to 0.1). Improvements were found in openness in communication (mean difference=0.4; 95% CI: 0.3-0.5) and error awareness (mean difference=0.3; 95% CI: 0.1-0.4).</p><p><strong>Conclusions: </strong>Interactive training during clinical placements was associated with limited improvements in self-reported error recognition and openness in communication. Further research is needed to determine whether these effects translate into safer clinical practice.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148978025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cynthia Porcari, Linda Denke, Folefac Atem, Yingzi Zhang, John C Mansour
{"title":"Count Discrepancies in the Operating Room: A Retrospective Chart Review.","authors":"Cynthia Porcari, Linda Denke, Folefac Atem, Yingzi Zhang, John C Mansour","doi":"10.1097/PTS.0000000000001561","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001561","url":null,"abstract":"<p><strong>Background: </strong>The surgical count is an important part of the surgical procedure and helps to prevent retained surgical items. This retrospective chart review examines risk factors for count discrepancies.</p><p><strong>Methods: </strong>We reviewed count documentation of surgical procedures (n=92,571) for 5 years between January 2019 and December 2023 at an academic medical center.</p><p><strong>Results: </strong>There was a notable higher percentage of cases with incorrect counts when the American Society of Anesthesiologists (ASA) classification is 4 or 5, more than one primary surgeon, 2 or more assisting surgeons, 4 or 5 circulating nurses, 3 or more scrub persons, longer OR time, and cases classified as add-on/urgent/emergent.</p><p><strong>Conclusions: </strong>Findings may assist leaders in developing strategies to mitigate risk factors for a count discrepancy.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148907724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kin Fung So, Lap Fung Tsang, Cheuk Fung Ng, Tak Po Cheung, Ka Po Lo, Siu Keung Tang, Lok Man Leung
{"title":"Development of the Physical Restraint Decision-Making Assessment Instrument: A Validation Study.","authors":"Kin Fung So, Lap Fung Tsang, Cheuk Fung Ng, Tak Po Cheung, Ka Po Lo, Siu Keung Tang, Lok Man Leung","doi":"10.1097/PTS.0000000000001581","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001581","url":null,"abstract":"<p><strong>Objectives: </strong>The use of physical restraints is a common practice in acute-care hospitals. Nonetheless, physical restraints are associated with adverse patient outcomes and ethical dilemmas. Currently, a comprehensive evidence-based instrument that can guide nurses through the complex decision-making process concerning the use of physical restraints is lacking. This study aimed to develop and validate the Physical Restraint Decision-Making Assessment Instrument to support and standardize nurses' decision-making regarding the use of physical restraints in acute-care settings.</p><p><strong>Methods: </strong>Instrument items were developed through a systematic review of the existing literature and interviews with stakeholder focus groups. A 2-round Delphi technique involving 5 multidisciplinary experts was used to establish content validity, which was assessed using the content validity index (CVI) and modified kappa coefficient (k*). Subsequently, 10 clinical teaching nurses evaluated face validity using the face validity index (FVI). Finally, 3 nurses independently assessed 30 patients to determine inter-rater reliability, with agreement measured using Fleiss' kappa.</p><p><strong>Results: </strong>The Delphi process refined an initial set of 36 items into a final 31-item instrument. This tool showed excellent content validity (scale-level CVI [S-CVI/Ave] of 0.99 for relevance and 0.99 for clarity) and satisfactory face validity (scale-level FVI [S-FVI/Ave] of 0.90). The inter-rater reliability was almost perfect, with Fleiss' kappa value of 0.822 (P<0.001).</p><p><strong>Conclusions: </strong>The instrument demonstrates strong psychometric properties and shows promise as a structured tool to support and standardize the complex decision-making process for applying physical restraints. Clinical effectiveness and impact on restraint rates and patient outcomes require confirmation through the planned randomized controlled trial before routine implementation is recommended.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148888983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Closing the Gap: Physician Perspectives on EMR Changes Needed to Support Safe Clinical Care.","authors":"Vittoria S von Petersdorff, David Schwappach","doi":"10.1097/PTS.0000000000001579","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001579","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to systematically assess the changes physicians identify as needed in their EMRs to better support safe clinical practice.</p><p><strong>Methods: </strong>Data were obtained from a national survey on EMR usability and patient safety conducted among Swiss physicians in 2024. Responses to the open-ended question \"What should change in 'MySystem' to better support you in working safely?\" were categorized inductively. When a respondent mentioned more than 1 change, these were split into separate statements. Inter-rater reliability was assessed in 2 rounds (subcategory κ=0.63, major category κ=0.70). Differences between physician subgroups were examined using a design-based F-adjusted test to account for clustering.</p><p><strong>Results: </strong>A total of 1479 statements from 809 physicians were categorized into 9 major categories and 24 subcategories. Improvements in usability were the most frequently expressed need (33.4%), followed by better workflow integration (12.4%) and integration of emerging features and technologies (12.2%). Significant differences were observed in the comments between hospital and medical practice physicians [F(7.82, 6321.44)=5.92, P<0.001], between residents and higher hierarchy physicians [F(7.83, 4760.09)=5.05, P<0.001], and between 4 major hospital EMR systems [F(21.58, 9410.64)=6.34, P<0.001].</p><p><strong>Conclusions: </strong>This study provides a systematic assessment of physicians' self-expressed EMR change needs in relation to patient safety. These needs differed substantially across EMR systems, work settings, and medical roles. Our findings indicate that changes are needed at 2 levels: direct modifications to EMR systems and changes to implementation and training practices. Systematically incorporating frontline clinician perspectives into EMR design, development, and implementation is essential to advancing patient safety.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148888858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Denise D Quigley, Lucy B Schulson, R Travis Merrill, Marc N Elliott, Andrew W Dick
{"title":"Trends in Inpatient Patient Safety Indicators Before and After the Onset of the COVID-19 Pandemic in the United States: 2018 to 2022.","authors":"Denise D Quigley, Lucy B Schulson, R Travis Merrill, Marc N Elliott, Andrew W Dick","doi":"10.1097/PTS.0000000000001582","DOIUrl":"10.1097/PTS.0000000000001582","url":null,"abstract":"<p><strong>Objectives: </strong>The COVID-19 pandemic challenged hospitals. Yet, little is known about the extent of COVID-19's impact on patient safety. We assessed change in Patient Safety Indicators (PSIs), which identify potentially preventable adverse events, before and after the onset of COVID-19 and when a hospital had a high proportion of COVID-19 admissions.</p><p><strong>Methods: </strong>Using Medicare Provider Analysis and Review data, our sample included 51,960,029 non-COVID-19 admissions eligible for inclusion in at least 1 PSI. This included 23,262,714 patients and a total of 294,871 PSI events. We fit risk-adjusted trends from 2018 to 2022 using interrupted time series models of PSIs before and after the onset of COVID-19. We also tested for the difference of a hospital having a high proportion of COVID-19 admissions. PSIs were categorized into provider-resource, surgical/team-resource, or hospital-resource-dependent events.</p><p><strong>Results: </strong>Ten (of 14) PSIs were worse after the onset of COVID-19 and had substantial increases in event rates, ranging from 14.6% (postoperative sepsis) to 51.9% (central venous catheter-related bloodstream infections). Also, when a hospital had a high proportion of COVID-19 admissions, 8 PSIs significantly worsened and had substantial increases in event rates, ranging from 5.9% (postoperative pulmonary embolism/deep venous thrombosis) to 15.8% (postoperative sepsis).</p><p><strong>Conclusion: </strong>The COVID-19 pandemic placed immense, prolonged strain on hospitals, resulting in a worsening of inpatient patient safety events. Increased rates of safety events occurred whether events were provider-resource, surgical/team-resource, or hospital-resource-dependent. These findings are a call for hospitals to return to placing heightened emphasis on reducing preventable harm and minimizing hospital complications and adverse events.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148889018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Journal of Patient SafetyPub Date : 2026-09-01Epub Date: 2026-03-20DOI: 10.1097/PTS.0000000000001488
Fasih A Ahmed, Farwa Ayub, Fozia Asif, Roha A Choudhary, Syed S Ul Hassan, Ghazal Haque, Tahir Munir, Khairulnissa Ajani, Zahra Tharani, Hamza Khan, Adil H Haider, Hanan J Aboumatar, Peter J Pronovost, Asad Latif
{"title":"Comparative Outcomes of a Patient Safety and Quality Improvement Curriculum Between Medical and Nursing Students.","authors":"Fasih A Ahmed, Farwa Ayub, Fozia Asif, Roha A Choudhary, Syed S Ul Hassan, Ghazal Haque, Tahir Munir, Khairulnissa Ajani, Zahra Tharani, Hamza Khan, Adil H Haider, Hanan J Aboumatar, Peter J Pronovost, Asad Latif","doi":"10.1097/PTS.0000000000001488","DOIUrl":"10.1097/PTS.0000000000001488","url":null,"abstract":"<p><strong>Background: </strong>Patient safety (PS) and quality improvement (QI) are nascent concepts for most low- and middle-income countries in their quest for improving health care delivery. However, few studies explore how different professional learners engage with the same curriculum. This study aimed to evaluate and compare the effectiveness of a 4.5-day-long course on QI and PS on the knowledge, self-efficacy, and systems thinking of medical and nursing students.</p><p><strong>Methods: </strong>A 4.5-day course on QI and PS, adapted from the Johns Hopkins patient safety curriculum, was implemented for a total of 4 batches of students, consisting of 2 batches of medical and nursing students at a private teaching hospital in Karachi, Pakistan. The course consisted of lectures, interactive sessions, and hands-on skill workshops. Students' knowledge, self-efficacy, and system thinking were evaluated through precourse and postcourse assessments. Qualitative analysis was conducted for students' personal reflections on the contents of the course.</p><p><strong>Results: </strong>Both groups showed significant improvement in scores for all 3 components of assessment following this course: knowledge, systems thinking, and self-assessment of PS knowledge (self-efficacy) ( P <0.001). Medical students started with lower baseline precourse scores for all components but showed greater improvement than nursing students in self-efficacy ( P <0.001 for all domains). Nursing students demonstrated statistically equivalent improvement for knowledge (mean difference: -0.41, 95% CI: -1.05 to - 0.23) and greater improvement in systems thinking (mean difference: -0.22, 95% CI: -0.33 to -0.10). Thematic analysis revealed profession-specific reflections, with medical students emphasizing patient safety in practice and nursing students prioritizing communication and infection control.</p><p><strong>Conclusions: </strong>This study highlights the feasibility and value of shared PS/QI training across professional groups. To maximize interprofessional learning, curricula should incorporate flexible strategies that accommodate discipline-specific perspectives, especially in LMICs where collaborative care models are critical to health system strengthening.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"e135-e142"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13492650/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147488083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Journal of Patient SafetyPub Date : 2026-09-01Epub Date: 2026-05-22DOI: 10.1097/PTS.0000000000001499
Suresh K Pavuluri, Evan Zahn, John Sather, Tyler Finocchio, Rohit B Sangal
{"title":"Eliminating a Latent Safety Threat in Emergency Care: A High-Reliability, Automated Strategy for Prostacyclin Continuity in Pulmonary Hypertension Patients.","authors":"Suresh K Pavuluri, Evan Zahn, John Sather, Tyler Finocchio, Rohit B Sangal","doi":"10.1097/PTS.0000000000001499","DOIUrl":"10.1097/PTS.0000000000001499","url":null,"abstract":"","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"e162-e163"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148018377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Journal of Patient SafetyPub Date : 2026-09-01Epub Date: 2026-06-03DOI: 10.1097/PTS.0000000000001533
Roshan Maria Abraham, Tamara Mckenzie, Stephen Kofi Amankwah, Kingsley Ikechukwu Enem, Manahil Ahmed
{"title":"Operating After Overnight Call: The Toll on Surgeon Well-Being.","authors":"Roshan Maria Abraham, Tamara Mckenzie, Stephen Kofi Amankwah, Kingsley Ikechukwu Enem, Manahil Ahmed","doi":"10.1097/PTS.0000000000001533","DOIUrl":"10.1097/PTS.0000000000001533","url":null,"abstract":"","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"e174"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148165138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}